Scalability and Data Integrity


Enhanced Process Optimization and Characterization Solutions

Advanced bioreactor, sensor and software solutions to accommodate the broad requirements of process optimization and characterization in the biotech and biopharma industry. Mimick your large scale process control approach and generate representative data.

 

Better Scale-Down Models


Advanced Functionality With Proven Track Record


Our BIOSTAT® benchtop fermenters | bioreactors have been used for decades in the biotech and biopharma industry for their process optimization and characterization requirements. The new BIOSTAT® B-DCU provides enhanced functionality, an unrivalled level of process control options for cell culture and microbial processes and full connectivity to third party supervisory software, making it the ideal scale-down model for your large scale process

 

Optimized and Controlled Feed Strategies


Improve Critical Quality Attributes and Yield


Data are shared on improving fed-batch and perfusion processes using on-line and in-line measurement techniques. In a fed-batch process, on-line glucose monitoring was used to establish an optimized and controlled feeding strategy leading to improved quality attributes and yield. In a perfusion process, different viable cell density measurement methods including in-line monitoring based on dielectric spectroscopy were compared to establish the basis for future control strategies.

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Easily Manage Processes and Data Across all Scales


SCADA Software for Reliable Data Acquisition, Monitoring and Control


The BioPAT® MFCS is designed as a “plug-and-play” tool for advanced SCADA functionalities. It is ideally suited for capturing, storing and visualizing process data of all BIOSTAT® and ambr® bioreactors and other process equipment. It is a 21 CFR Part 11 compliant feature-rich, GAMP 5 category 4 software package. Besides the core functionality of a full-fledged SCADA system, it also provides advanced chemometrics tools for data analysis and experimental design.

Process Characterization Made Easy with Integrated Chemometrics Software Tools


Simplify your DOE and Seamlessly Gather Data to Build MVDA Modells


Use BioPAT® MODDE software to speed up your development work, increase productivity and elucidate primary effects and interactions of potential critical process parameters on critical quality attributes. BioPAT® SIMCA enables you to effectively explore your data, analyze your process and interpret the results allowing you to make the right decisions quickly and confidently.

True Scalability in Single-Use


Simplify Your Scale-Up and Scale-Down and Minimize the Risk for Process Transfers


BIOSTAT STR® makes simplified scalability possible thanks to its classic stirred-tank design, comparable mixing and gassing strategies and reliable single-use sensor platform.

 

Speed to Clinic


Ready-To-Use Bioanalytical & Biosafety Assays


BioOutsource offer a range of services to support the testing of biologic drugs and vaccines throughout preclinical development, manufacturing and lot release. In particular, BioOutsource specialise in biosimilar testing services for monoclonal antibodies.


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